BioCentury
ARTICLE | Clinical News

Axanum low dose aspirin/esomeprazole magnesium regulatory update

August 8, 2011 7:00 AM UTC

AstraZeneca said 23 countries in the EU and Norway issued a positive agreement for approval of an MAA for Axanum aspirin/esomeprazole to prevent cardiovascular events in high risk cardiovascular patients requiring daily low-dose aspirin treatment who are at risk of gastric ulcers. The MAA was submitted last year under the EU's decentralized procedure, with Germany acting as the reference member state. Axanum is a combination of low-dose aspirin and esomeprazole magnesium. ...